Indivior PLC announced that it has filed a regulatory submission with Australia’s Therapeutic Goods Administration (TGA) for Sublocade (buprenorphine extended-release) injection, for subcutaneous use, for the treatment of opioid dependence within a framework of medical, social and psychological treatment. If approved, Sublocade will be marketed by Indivior Pty Ltd in Australia.
“Illicit drug use is a serious public health issue in Australia. In 2016, the country saw the highest number of drug deaths in the past twenty years, with illicit opioid use alone contributing to more than a thousand deaths,” said Shaun Thaxter, chief executive officer of Indivior. “As a company, our vision is that all patients around the world have access to evidence-based treatment for the chronic and co-occurring disorders of addiction. We look forward to working closely with regulatory authorities to help make Sublocade, if approved, available to healthcare providers and patients in Australia.”
The TGA submission follows the approval of Sublocade by the US Food and Drug Administration (FDA) on November 30, 2017, and the New Drug Submission (NDS) to Health Canada on April 20, 2018.In Australia, Sublocade is an investigational product and its safety and efficacy is currently under review by the TGA.
In the US, Sublocade is indicated for the treatment of moderate to severe opioid use disorder (OUD) in adult patients who have initiated treatment with a transmucosal buprenorphine-containing product, followed by dose adjustment for a minimum of seven days. It should be administered only by healthcare providers and should be used as part of a complete treatment programme that includes counseling and psychosocial support. Sublocade has a boxed warning in the us and is available through restricted distribution under the Sublocade risk evaluation and mitigation strategy (rems) programme.
Sublocade uses the ATRIGEL delivery system, which consists of a polymeric solution of a biodegradable poly-(DL-lactide-co-glycolide) co-polymer dissolved in N-methyl pyrrolidone (NMP), a water-miscible biocompatible solvent. After subcutaneous injection, NMP diffuses out of the polymer matrix and the polymer precipitates, trapping the drug inside and forming an amorphous solid depot in situ. The depot releases buprenorphine over a one-month period by diffusion as the polymer biodegrades.